Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations
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|ClinicalTrials.gov Identifier: NCT03130660|
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ultrasonography Central Line Complication||Device: Ultrasonography||Not Applicable|
Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.
Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.
Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.
- Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
- Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
- Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.
All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.
Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||patient to be randomized to two groups|
|Masking:||None (Open Label)|
|Official Title:||Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.|
|Actual Study Start Date :||April 20, 2017|
|Actual Primary Completion Date :||April 19, 2018|
|Actual Study Completion Date :||April 19, 2018|
Experimental: Short Axis Ultrasonography
one person does both ultrasound and line insertion
Ultrasound guidance for central line
Experimental: Long Axis Ultrasonography
one person does ultrasound and another inserts the central line
Ultrasound guidance for central line
- time to insertion [ Time Frame: 15 minutes ]time from skin puncture to insertion of guidewire
- Total Procedure time [ Time Frame: 15 minutes ]Time from when Ultrasound scan was started to complete suturing of the CVC line.
- Number of needle sticks [ Time Frame: 15 minutes ]Number of time punctures were done in the skin
- Complications [ Time Frame: 48 hours ]hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130660
|IMS and SUM Hospital|
|Bhubaneswar, Odisha, India, 751007|
|Study Director:||Arun Rath, MD||IMS and Sum hospital|